Formulation and Evaluation of Phenylephrine Nasal Gels

International Journal of Clinical Pharmacokinetics and Medical Sciences Pub Date : 2024-02-02 DOI:10.26452/ijcpms.v4i1.573

Ameer Pasha Shaik, Sowmy Adapa

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Abstract

The primary objective of this study is to develop and evaluate phenylephrine nasal gels, aiming for stable blood levels with lower drug doses through consistent administration, avoiding first-pass hepatic metabolism. Compatibility among the drug, polymers, and lipids was confirmed using FTIR and DSC spectra. Phenylephrine nasal gels were formulated, and their clarity assessed. The gels (ONGF1-ONGF8) had pH values of 6.1-7.2, spreadability of 18.33-21.62 g/cm/sec, and viscosity of 934.2-966.2 centipoises. Drug concentration in these formulations varied from 85.52% to 98.88%, indicating acceptable medication content. Gel strength ranged from 64% to 95%. In-vitro drug release of phenylephrine showed 77% to 95% diffusion for ONGF1. The release kinetics followed first order, zero order, Higuchi model, and Korsemeyer-Peppas equations. Kinetic values for all formulations were tabulated. ONGF1 exhibited the most efficient release, with 95% of the drug released within 7 hours, demonstrating a diffusion mechanism followed by non-Fickian transport, adhering to both zero order and Korsemeyer-Peppas models.Top of Form

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苯肾上腺素鼻凝胶的配制和评估

本研究的主要目的是开发和评估苯肾上腺素鼻腔凝胶，旨在通过持续给药，以较低的药物剂量达到稳定的血药浓度，避免首过肝脏代谢。利用傅立叶变换红外光谱和 DSC 光谱确认了药物、聚合物和脂质之间的相容性。配制出了苯肾上腺素鼻腔凝胶，并对其透明度进行了评估。凝胶（ONGF1-ONGF8）的 pH 值为 6.1-7.2，铺展性为 18.33-21.62 克/厘米/秒，粘度为 934.2-966.2 厘泊。这些制剂中的药物浓度从 85.52% 到 98.88% 不等，表明药物含量可以接受。凝胶强度从 64% 到 95% 不等。体外药物释放显示，ONGF1 的苯肾上腺素扩散率为 77% 至 95%。释放动力学遵循一阶、零阶、Higuchi 模型和 Korsemeyer-Peppas 方程。所有配方的动力学值均已列表。ONGF1 的释放效率最高，在 7 小时内释放了 95% 的药物，这表明其扩散机制遵循非费克运移，符合零阶和 Korsemeyer-Peppas 模型。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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International Journal of Clinical Pharmacokinetics and Medical Sciences

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